The Department of Transportation's (DOT) operating administrations (Federal Aviation Administration, Federal Highway Administration, Federal Railroad Administration, United States Coast Guard, Federal Transit Administration, and Research and Special Programs Administration) have issued regulations requiring anti-drug programs in the aviation, highway, maritime, mass transit, and pipeline industries.
The DOT operating administrations' rules require that employers conduct drug testing according to provisions of 49 CFR Part 40, "Procedures for Transportation Workplace Drug Testing Programs," Final Rule, published in the Federal Register on Dec. 1, 1989 (54 FR 49854), revised on Feb. 15, 1994 as "Procedures for Transportation Workplace Drug and Alcohol Testing Programs" (59 FR 7340) and amended on Aug. 19, 1994 (59 FR 42996). The procedures in 49 CFR 40 are based on the Department of Health and Human Services' "Mandatory Guidelines for Federal Workplace Drug Testing Programs," published in the Federal Register on Apr. 11, 1988 (53 FR 11970) and revised on Jun. 9, 1994 (59 FR 29908). All of the above-cited rules and regulations are incorporated herein by reference.
The procedures for collection of urine under these rules are very specific and must be followed whenever a DOT required urine collection (for a drug test) is performed. The only exception is the Federal Railroad Administration's Post-Accident Toxicological Testing Program in the collector will be provided specific instructions and a testing kit by the railroad representative. These procedures (including the mandatory DOT custody and control form) apply only to DOT required testing. While employers can use these procedures for testing under employer or state authority, they are not required by Federal regulations to do so.
All urine specimens taken in compliance with DOT rules must be collected while maintaining chain of custody. Chain of custody is the term used to describe the process of documenting the handling of a specimen from the time a donor gives the specimen to the collector, during the testing at the laboratory, and until the results are reported by the laboratory. For specimens collected under Federal regulations, an Office of Management and Budget (OMB) approved Custody and Control Form (CCF) must be used to document the collection of a specimen. A representative prior art form is shown in perspective view in FIG. 1, although the CCF may be configured and manufactured in a variety of ways as long as it meets certain legal requirements and is approved by the OMB. The OMB-approved CCF can be supplied by a number of different sources (e.g., laboratories, collectors, Medical Review Officers (MROs)) without being modified; however, it is usually provided by the laboratory. There is a space provided at the top of the form to allow the laboratory to preprint its own name and address. If the form does not have the preprinted laboratory name and address, the collector must ensure that the name and address of the laboratory receiving the specimen are printed on the top of the form. If the CCF uses a barcode for the specimen identification number, there must be a human readable number associated with the barcode. The OMB number must appear on each copy of the CCF.
Pursuant to regulations, the CCF consists of the following seven copies with the color of each copy noted in parentheses:
Copy 1. Original-Must Accompany Specimen to Laboratory (White) PA1 Copy 2. Second Original-Must Accompany Specimen to Laboratory (White) PA1 Copy 3. Split Specimen-Must Accompany Split Specimen to Laboratory (White) PA1 Copy 4. Medical Review Officer Copy (Pink) PA1 Copy 5. Donor Copy (Green) PA1 Copy 6. Collector Copy (Yellow) PA1 Copy 7. Employer Copy (Blue) PA1 Check block marked "Yes" if temperature is within range. PA1 If specimen temperature is not within range, check block marked "No" and record specimen temperature. PA1 Secure caps on both specimen bottles and affix specimen bottle seal labeled A over the cap and down the sides of the primary specimen (bottle containing at least 30 ml of urine). PA1 Affix specimen bottle seal labeled B (split) on the split specimen (bottle containing at least 15 ml of urine) in same manner. PA1 Record date on both specimen bottle seals. PA1 FOR SINGLE SPECIMEN COLLECTION ONLY. PA1 Secure cap on specimen bottle (containing at least 30 ml of urine) and affix specimen bottle seal labeled A over the cap and down the sides of the specimen bottle. PA1 Record date on specimen bottle seal. PA1 Instruct donor to initial the specimen bottle seal. PA1 Instruct donor to complete STEP 4. PA1 Ensure donor provides his/her daytime and evening phone number and date of birth. PA1 Instruct donor to read certification statement. Ensure donor prints his/her name and signs and dates the certification statement. PA1 Upon completion, check donor entries, return to Copy 1. PA1 Complete the name and address of the facility at which the collection is taking place. PA1 List a business telephone number where collector can be reached. PA1 Place a check in the box indicating whether or not a split specimen was collected. PA1 Record any unusual occurrences concerning the collection (e.g. donor refusal to provide information/sign certification statement, specimen collected under direct observation, suspected adulteration) in the remarks section. PA1 Collector completes collection certification section by printing and signing his/her name, recording the date and time of collection. Be sure to circle A.M. or P.M. PA1 Record date of collection. PA1 In the "Specimen Received By" column, sign and print your name indicating that you have received the specimen from the donor. PA1 The "Purpose of Change" entry in the next column is pre-printed (Provide Specimen for Testing) and explains the transfer of the specimen from the donor to the collector. PA1 On the next line, record the date the specimen was released by you. PA1 Upon completing Step 6, give donor her/her copy, Copy 5, (green page) of the Drug Testing Custody and Control Form. PA1 Donor may leave the collection site at this point. PA1 If a split specimen collection was performed, place both specimen bottles and Copies 1, 2 and 3 of the Drug Testing Custody and Control Form in the shipping container. PA1 If a single collection was performed, place the specimen bottle and Copies 1 and 2 of the Drug Testing Custody and PA1 Control Form in the shipping container. Discard Copy 3 PA1 Secure the shipping container. On the shipping container seal, record your initials and the date. PA1 Send Copy 4 (pink page) directly to the Medical Review Officer. Do not send to laboratory. PA1 Retain Copy 6 (yellow page) for your records. PA1 Forward Copy 7 (blue page) to the employer. Do not send to laboratory.
Note: Copy 3 is discarded for single specimen collection. The reverse side of Copy 7 gives instructions on completing the CCF. Representative instructions, reprinted from an actual CCF form, are as follows: